ES2247756T3 - INTRAVAGINAL SET AND METHOD OF TREATMENT OF UROGENITAL ORGAN PROLAPSE. - Google Patents

Abstract

An intravaginal set for treatment of prolapse of urogenital organs and urinary stress incontinence or in the period of intervals in women when the intravaginal therapeutic insert for treatment of static disorders of the urogenital organs and urinary stress incontinence is not currently inserted, said method being realised by means of an intravaginal set of inserts, that permits selecting the appropriate size of corrective insert from a subset of intravaginal corrective inserts, consisting of at least two balls with step increase in diameter, ranging between the minimal and maximal woman vaginal diameter, each ball being preferably hollow, each ball has the loosely hanging string and each ball is made preferably of medical material, such as polycarbonate or methyl methacrylate, said selecting being realised by means of an intravaginal measuring subset comprising at least two metal or plastic balls having graduated diameters corresponding to graduated diameters of the balls from the subset of the intravaginal corrective inserts, which balls instead of the loosely hanging string have a rigidly mounted linearly scaled slat for measurement of optimal diameter and depth of localization of the corrective insert in the vagina, depending an actual and individual anatomical conditions of urogenital organ of the woman being treated, by the selection of appropriate optimal diameter and depth of localization of the corrective insert in vagina by approximations with using the balls from the measuring subset, so that contraction of the levator ani muscle will cause the elevation of the insert and the elevation of the insert will cause the elevation of the uterus and/or correction of the cysto-urethral angle. <IMAGE>

Description

Intravaginal set and method of treatment of prolapse of urogenital organs.

The present invention relates to a set intravaginal, used in the case of organ prolapse urogenital and stress urinary incontinence, or in the period of intervals, in which a insert for the treatment of organ disorders Urogenital and stress urinary incontinence.

Aging and past births give as result in weakening and lengthening of the perineal muscles which leads to the prolapse of the urogenital organs and others anatomical disorders Once lengthened, the muscles become weaker and weaker what later results in advances from prolapse to total erosion of the uterus. As the channel vaginal is "locus minoris resistentiae" on the pelvic floor, the walls of the vagina can become the ring of hernia (Cystole, urethrole, and rectocellus).

In the course of progressive prolapse of the organs urogenital, abdominal discomfort intensifies inferior, from "discomfort" to pain, and the stress urinary incontinence.

The prolapse of the urogenital organs produces a decrease in the distance between the cervix and the entrance of the vagina, fall of the anterior wall of the vagina together with the urinary bladder and urethra (the angle cysto-uretal becomes more obtuse), and the urethra dislocates out a range of pressure performance intra-abdominal

This causes a decrease in blood flow from the urogenital organs due to venous constriction.

In less advanced cases of urogenital prolapse, special therapeutic exercises are recommended to strengthen the pelvic floor muscles.

Physical exercises can only increase the cross striated muscle performance, i.e. muscles that depend on our own will while balance of the urogenital organs is also maintained by smooth muscles independent of our will, controlled by the system autonomic nervous Smooth muscles build the urinary bladder, the urethra, the internal sphincter muscle of the urethra, and the muscles of the uterine ligaments that fix the uterus in position normal.

By developing an insert therapeutic progress has been made in the treatment of static disorders of the urogenital organs (the subject of the Descriptive report of Polish Patent No. RP 138,406), which it consists of a hollow ball with a rope attached freely outside of the ball, and the smallest metal ball, freely located in its inside. This device generates mechanical impulses that stimulate contractions of surrounding muscles, smooth and striated-crossed. A metal ball placed freely in the intravaginal therapeutic piece generates the impulses mechanics hitting your capsule as a result of transposition of the center of gravity when walking. The mechanical impulse stimulates the muscle contraction. Periodic muscle exercise produces hypertrophy in the muscles and an increase in muscle strength. The Therapeutic insert can be applied twice a day, over a period of approximately 30 minutes.

Prolonged application of more than 30 minutes It leads to excessive muscle fatigue and abdominal pain. A daily application of the therapeutic insert during a three month period leads to therapeutic results satisfactory in the treatment of small prolapse of the urogenital organs (grade I), while in more advanced cases (grades II, III, IV) no improvement was observed.

The most likely explanation is such that in a more advanced urogenital prolapse, the uterus falls during intervals between therapy applications, which produces effects unfavorable, (isometric contraction, passive congestion).

When conservative therapy is not effective, it perform reconstruction surgery to restore normal position of the urogenital organs.

Depending on the symptoms, age and progress of the disease, different treatment strategies are used therapeutic doctor. From about 200 modifications applied to correct the position of urogenital organs, the Basic medical treatment involves cutting the muscles and ligaments Such therapeutic medical treatment improves the position but it does not restore normal muscle function and therefore duration and full recovery.

In the case of contraindications for surgery, the prosthesis device can be applied to ensure a normal position of the urogenital organs.

One of them is the intravaginal disc well known for the support of fallen or prolapsed uterus. This disc it is applied in such a way that its ring surrounds the cervix, thus preventing the prolapse of the uterus by prolonging the vaginal wall in the area of the posterior vaginal fornix. A disadvantage of this design is the difficulties in application and extraction, which makes its use impossible, when The therapeutic insert is not currently used. As the disc is placed on top of the vagina, it does not transmit the elevating anal muscle contraction, therefore the uterus is not raise.

The respective British patent application describes a flat plastic arc, whose widest arm rests on the pubic symphysis, while the second, the narrow arm presses the urethra against the urinary bladder. The maximum time of intravaginal application is two hours which limits the usefulness of This device in unlimited time. The mode of action consists of local compression of the urethra, which can lead to a inflammation and pressure sores.

There is also a well disposable vaginal package known (made in Germany), which is placed in the vagina during a period of up to eight hours, its mode of action consists of a gentle compression of the urethra and an adjustment to the vagina after soak with water before intravaginal application. Do not However, this vaginal package does not fulfill the corrective functions, and can produce inflammatory states in the case of presence prolonged intravaginal Soaking with vaginal discharge may produce a distended vagina that leads to prolapse progressive uterus and urinary bladder.

U.S. Patent No. 6,530,879 of corresponding applicant includes a re-quote technique previous that fulfills the desire for honesty on the part of the Applicant to the Patent and Trademark Office of the United States. The list of previous publications includes two papers by Burton and others who report their own device of the applicant KOLPEXIN T (registered trademark) corresponding to the "therapeutic insert" described herein descriptive For the description of a vaginal insert in a cable to train the pubo-coxigee muscle in a contraction and rhythmic relaxation that makes the insert oscillate in the vaginal cavity, see the document US-A-4574791.

The object of the present invention is to design a intravaginal set for a treatment method to obtain a Optimal permanent position of the uterus and urinary bladder.

An intravaginal assembly according to the invention it is useful in the case of prolapse of the urogenital organs and of stress urinary incontinence, or in women during period of intervals in which a intravaginal therapeutic insert for the treatment of static disorders of the urogenital organs and of the stress urinary incontinence, whose piece inserts Therapeutic consists of a hollow plastic ball with a rope united and moving freely out of the ball, and with a ball smaller, freely placed within said hollow ball of plastic, whose smallest ball has a tight weight properly to generate mechanical impulses that stimulate alternate contractions of smooth muscles, said said intravaginal set a subset of corrective inserts intravaginal and an intravaginal subset of measurement for determine the size of the insert in which the subset of intravaginal corrective parts comprises at least two balls with stepped increase in diameter, which varies between the minimum and the maximum vaginal diameter of women, each ball being preferably hollow, each ball has the rope to hang loosely and each ball is preferably made of medical material, such as polycarbonate or methyl methacrylate, while the subset of intravaginal measurement comprises at least two balls made of metal or plastic with graduated diameters corresponding to the graduated diameters of the balls of the subset of inserts, whose measuring balls instead of the loose hanging rope has rigidly mounted a graduated splint preferably of linear form for measuring the optimal diameter and the depth of placement of the insert inserted into the vagina, which it depends on the real and individual anatomical conditions of the Urogenital organs of the woman being treated.

The invention allows a method of treatment of urinary incontinence urogenital organs prolapse by efforts, or in the period of intervals in women in whom the intravaginal insert is not currently inserted Therapy for the treatment of static disorders of urogenital and stress urinary incontinence organs, select the correct corrective insert piece size subset of intravaginal corrective inserts, said selection being made by the intravaginal subset of measurement, by selecting the appropriate optimal diameter and the depth of placement of the corrective insert in the vagina by approximations with the use of subset balls of measurement, so that the contraction of the anal elevator muscle will produce the elevation of the insert and the elevation of the insert will cause the elevation of the uterus and or the elevation of the cysto-uretal angle, and during the progress of said Treatment sizes of successive corrective inserts applied are adjusted by the analog selection of the optimal diameter appropriate and the depth of placement of the measuring ball in the vagina, and advantageously to carry out the exercises of the pelvic floor muscles of the treated woman lying in position of prone genocubital in the interval between successive substitutions of the corrective inserts.

An application of the corrective insert intravaginal allows the maintenance of the insert in the vagina for an indefinite period of time. The diameter of the insert, selected thanks to the measuring device, should ensure permanent correction of uterine placement and of the bladder, so that the wall of the vagina was not too tense, and for a mass of fallen organs not to produce the prolapse of the piece inserted in the vertical position.

Correction of organ placement urogenitals and reduction of contraction muscles isometric that hold urogenital organs result in the restoration of normal blood supply, allowing them regenerate and also prevent the progressive fall of the organs urogenitals Cysto-uretal angle correction It allows the control of normal urination.

The corrective insert of the assembly that is the subject of the invention is used in the interval between applications of the therapeutic insert and exerts effects beneficial in muscles by eliminating contraction isometric and the best preparation for dynamic contraction that It follows the application of the therapeutic insert. A alternate application of the therapeutic insert and the part corrective insert allows the treatment of the most advanced cases of urogenital prolapse and improves therapy results until 80%

The corrective insert applied alternatively with the therapeutic insert, adjusted properly, subject to the uterus in its optimal placement and due to Its spherical shape, can be freely moved and rotated in different directions, thus preventing pressure ulcerations. The invention will be described in more detail (by way of an example illustrative) in relation to the drawings in which Figure 1 shows a subset of the corrective inserts intravaginal of the set that is the subject of the invention, the Figure 2 shows the measurement subset of the set that is the Subject of the invention, Figure 3 is a sagittal cross section of the woman's pelvis with the cysto-uretal angle increased to almost 180º, when low urination has begun control or inadvertently, Figure 4 is a cut sagittal cross section of woman's pelvis with insert corrector of the set that is the subject of the invention producing cysto-uretal angle correction so that the resulting angle is straight or obtuse; with this angle, the uretal closure mechanism is very effective, and Figure 5 it is also a sagittal cross section of the woman's pelvis and that shows a method of measuring the diameter of the vagina to determine the optimal placement and size of the insert corrective

The intravaginal set that is the subject of the invention consists of the subset of intravaginal pieces correctors (Figure 1) which are preferably hollow balls 1 with stepped increase in diameter, which vary between the minimum and the maximum vaginal diameter Each ball 1 has the hanging rope of Loose way 2 and are preferably manufactured from plastics medically inert, such as polycarbonate or methyl methacrylate, and the set also consists of the measurement subset intravaginal (Figure 2) containing measuring balls 3 manufactured  preferably of metal or plastic with graduated diameters that correspond to the graduated diameters of balls 1 of subset of intravaginal corrective inserts of the Figure 1; which balls 3 instead of the hanging rope so loose they have, rigidly mounted, a graduated splint 4. Tablet 4 is preferably graduated for measurements of diameter and for the optimal location of the insert corrector in the vagina in the case of urinary incontinence due to efforts

Figure 3 shows a sagittal cross section Simplified woman's pelvis with angle cysto-uteral increased almost to 180º, when the urination is controlled or involuntary.

Figure 5 shows the measurement method of diameter of the vagina using ball 3 of the subset of measurement to determine the depth of placement and size of The corrective insert. The appropriate anatomical size is adjust using balls 3 of the measurement subset. After of the adjustment, it is checked if the measuring insert is not Eject out by the fallen organs. In this case, it should be Apply a larger insert diameter. In the case of urgency, the insert is placed very high, then you must apply a Smaller insert.

The application of corrective insert intravaginal is to determine the optimal diameter of the piece insert and intravaginal application of the corrective insert intravaginal for an indefinite period of time.

Figure 4 shows a sagittal cross section of the woman's pelvis with the corrective insert with the properly selected diameter of the ball 1 thanks to measuring subset, and the rope 2 is used to extract the insert.

The mode of action of the insert is like continue: the insert that is placed in the vagina is held in the anal lift muscle This results in a shift forward and upward from the anterior wall fall of the vagina and an elevation of the urethra and urinary bladder. A urethral elevation restores its normal position with respect to the posterior wall of the urinary bladder (angle reduced cysto-uretal shown in Figure 4). In In the case of concomitant uterine prolapse, the insert produces Uterine elevation

An application of the corrective insert of the set that is the object of the invention results in a Very fast pain relief. The device also allows a urination control due to angle correction cysto-uretal without removing the part Insert to urinate.

The displacement of the uterus to the "pure zone" It allows the total elimination of inflammation. The relaxation of muscles and fasciae restores normal blood supply to the organs of the pelvis minor. It is very likely that the insert corrector improve the results of the treatment with the piece therapeutic insert. The alternate application of the insert Therapeutic and corrective insert allows the treatment of more advanced cases of urogenital fall and improves outcomes of therapy.

The insert can be applied and removed easily. It rests on the back wall of the vagina at the level of the elevator muscle of the anus, thus preventing excessive extension of the vaginal walls.

The corrective insert of the assembly that is the subject of the invention supports the prolapsed uterus and blocks the urethra in case of stress urinary incontinence, occlusion inadequate urethral due to increased intra-abdominal pressure. An adjustment Optimum diameter of the insert inserted into the vagina allows regenerate muscles by reducing uterine pressure and cystic The corrective insert supports these organs, and after regeneration, the muscles will withstand again the uterus and urinary bladder but in a corrected position.

With the use of the intravaginal set it is allowed a method of treatment of prolapse of urogenital organs and urinary incontinence due to efforts in women. What distinguishes This method is that the correct corrective insert is select from the subset of corrective inserts intravaginal, consisting of at least two balls with augmentation staggered in diameter, which vary between, the vaginal diameter maximum and minimum, each ball being preferably hollow, has the Hanging rope loose and is made of medical material, such as polycarbonate or methyl methacrylate, and consists of the intravaginal measurement subset containing at least two metal or plastic balls with diameters corresponding to the diameters of the intravaginal corrector subset balls that instead of the loose hanging rope, it is mounted so rigid, a graduated splint, for measuring the diameter and Optimal placement of the insert in the vagina, depending on the individual anatomical conditions of the urogenital organ in the woman, by selecting the appropriate diameter and depth of vaginal placement through ball approaches significant subset of the measurement, so that the contraction of the anal elevator muscle causes the elevation of the insert and lifting the insert produces the Uterine elevation and / or angle correction cysto-uretal, and during the progress of said treatment the sizes of the inserts applied successively adjust by diameter selection and proper placement depth in the vagina and results beneficial to perform floor muscle exercises pelvic lying in prone or genocubital position between successive replacements of the insert.

The size of the insert gradually decreases under medical supervision using the measuring device and ensures permanent correction of the placement of the uterus and bladder by correcting the cysto-urethral angle a , so that diffuse muscle fibers in the surrounding tissue can restore the fallen organs to their primary position.

In the case of major urogenital prolapse, the uterus is at the same level as the anal muscle arms of elevation, increasing the distance between them.

In this case, an exercise of the anal muscle lift, because muscle contraction exerts pressure in the fallen uterus without concomitant elevation. In this case the intravaginal corrective insert produces an elevation of uterus while lifting anal muscle contractions They raise the insert and, indirectly, the uterus. The piece corrective insert can be expelled by muscle contraction when its diameter is too small. It is advantageous to do the anal contraction test of the elevation muscle following a adjustment of the corrective insert using the device measurement.

An anal muscle lift exercise with the Use of the corrective insert leads to improved efficiency of the anal lift muscle, vaginal stenosis and elevation of the uterus

It is necessary to check the position of the piece inserted and the uterus two weeks after the start of the exercise recommended.

In cases of advanced urogenital prolapse in the that the cervix is placed below the arms of the muscle anal lift, a muscle exercise with the use of the piece corrective insert elevates the uterus with a decrease in distance between the two arms; the insert rises, giving as a result a uterine lift.

The progress of therapy can be monitored using the measuring device to examine the commonly called pelvic floor thickness, that is following the application, the measuring device is pushed slightly towards down to make him rest in the arms of the anal muscle of elevation and distance of the pubic symphysis is read in the graduated tablet

An evaluation of the therapeutic effect includes repeated measurements of the optimum diameter of the insert corrective

Claims (5)

1. A set of intravaginal treatment, used in the case of prolapse of the urogenital organs and stress urinary incontinence, or in the interval period in women in whom a piece is not currently inserted Therapeutic intravaginal insert for the treatment of disorders static urogenital organs and incontinence urinary stress, whose therapeutic insert consists of a hollow plastic ball with a attached string that moves freely out of the ball, and with a smaller ball, located freely within said hollow plastic ball, whose ball more small has a properly adjusted weight to generate impulses mechanics that stimulate alternate muscle contractions smooth, said treatment set comprising a subset of intravaginal corrective inserts for lifting the uterus and an additional subset of measuring inserts intravaginal to determine an optimal size of the insert intravaginal corrector; in which the subset of inserts intravaginal correctors comprises at least two corrective balls (1) with stepped increase in diameter, which oscillates between the diameter vaginal of minimum and maximum woman, having each one of said balls you will correct a rope (2) that hangs loosely to remove it from the vagina while the measurement subset intravaginal comprises at least two balls (3) with diameters graduates that correspond to the graduated diameters of the balls (1) of the subset of intravaginal corrective inserts, whose measuring balls (3) instead of the extraction means (2) they have a splint or blade (4) rigidly mounted on each ball (3) of the measurement subset for the measurement of a diameter and depth of location of the corrective insert in the vagina, which depends on the anatomical conditions present and individual urogenital organs of the woman being treated, which is optimal for the elevation of the uterus. 2. The intravaginal assembly as claimed in claim 1, characterized in that each ball (1) of the subset of corrective inserts is hollow. The intravaginal assembly as claimed in each of the preceding claims, characterized in that each ball (1) of the subset of corrective inserts is made of a medical material that is polycarbonate or methyl methacrylate. 4. The intravaginal assembly as claimed in each of the preceding claims, characterized in that each ball (3) of the measuring subset is made of metal or plastic. 5. The intravaginal assembly as claimed in claim 4, characterized in that the tablet (4) has a linear measurement scale.